Posted opportunity — confirm at source
First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
National Institutes of Health · PAR-25-180
See source for award amount
2027-10-15-00-00-00
Confirm exact timezone in the announcement.Public and State controlled institutions of higher education, For profit organizations other than small businesses, Special district governments, Others (see text field entitled "Additional Information on Eligibility" for clarification), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Native American tribal organizations (other than Federally recognized tribal governments), Small businesses, County governments, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Private institutions of higher education, State governments, Independent school districts, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, City or township governments
Geographic eligibility and all attachment-specific conditions require review of the original announcement.
Eligibility details
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Matching funds & resources
Source matching-funds field: Not Required.
Matching funds and leveraged resources are different requirements. Read the description and reviewed rules below before determining resource commitments.
About this opportunity
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs, or novel neuromodulatory devices for the treatment of psychiatric disorders in areas of unmet medical need. The NOFO will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase II studies of novel agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drugs impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The NOFO also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private or other public funding for further clinical development as FDA-approved treatments. A key aspect of this NOFO is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.
Funding geography: Not specified — review source. A funder’s address does not establish eligibility.
Review original source ↗Funding instrument: Cooperative Agreement. Issuing jurisdiction: Federal. This is not a geographic eligibility determination.
Source fields and evidence
id: 357424
Source ↗ · id
opportunityNumber: PAR-25-180
Source ↗ · opportunityNumber
opportunityTitle: First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Neuromodulatory Device-based Interventions for Psychiatric Disorders (U01 Clinical Trial Required)
Source ↗ · opportunityTitle
revision: 0
Source ↗ · revision
agencyDetails: {"code":"NIH","seed":"HHS-NIH11","agencyName":"National Institutes of Health","agencyCode":"HHS-NIH11","topAgencyCode":"HHS"}
Source ↗ · agencyDetails
owningAgencyCode: HHS-NIH11
Source ↗ · owningAgencyCode
cfdas: [{"id":425716,"opportunityId":357424,"cfdaNumber":"93.242","programTitle":"Mental Health Research Grants"},{"id":425718,"opportunityId":357424}]
Source ↗ · cfdas
applicantTypes: [{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"04","description":"Special district governments"},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"23","description":"Small businesses"},{"id":"01","description":"County governments"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"20","description":"Private institutions of higher education"},{"id":"00","description":"State governments"},{"id":"05","description":"Independent school districts"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"02","description":"City or township governments"}]
Source ↗ · applicantTypes
applicantEligibilityDesc: Other Eligible Applicants include the following:
Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Source ↗ · applicantEligibilityDesc
fundingInstruments: [{"id":"CA","description":"Cooperative Agreement"}]
Source ↗ · fundingInstruments
fundingActivityCategories: [{"id":"HL","description":"Health"}]
Source ↗ · fundingActivityCategories
awardFloor: none
Source ↗ · awardFloor
awardCeiling: none
Source ↗ · awardCeiling
responseDate: Oct 15, 2027 12:00:00 AM EDT
Source ↗ · responseDate
responseDateStr: 2027-10-15-00-00-00
Source ↗ · responseDateStr
costSharing: false
Source ↗ · costSharing
lastUpdatedDate: Nov 27, 2024 10:03:18 AM EST
Source ↗ · lastUpdatedDate
status: posted
Source ↗ · oppHits[id=357424].oppStatus
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